Treatment patterns among patients with moderate-to-severe ulcerative colitis in the United States and Europe.

The aim of the present study is to examine how moderate-to-severe ulcerative colitis (UC) is currently managed in real-world clinical practice across the United States (US) and European Union Five (EU5; France, Germany, Italy, Spain, and the United Kingdom). Data from the 2017 Adelphi Inflammatory Bowel-Disease Specific Programme (IBD-DSP) were used. The IBD-DSP is a database of patient chart information abstracted by selected gastroenterologists across the US and EU5. Eligible gastroenterologists who agreed to participate were asked to complete patient record forms for the next seven consecutive eligible adult patients with UC. Only charts from patients with moderate-to-severe UC were included in the analysis (defined as those with documented administration of either an immunosuppressant [IM] or a biologic). Treatment patterns were reported descriptively. 411 and 1191 patient charts were included in the US and EU5 (mean ages 44.2 and 39.6 years; 53.0% and 43.5% female), respectively. For those with complete treatment history, 40.7% and 52.9% used either an IM or biologic as their first treatment (with or without steroids). Usage of these therapies increased in subsequent lines. The percentage of patients treated with combination therapy (i.e., biologic therapy with a concomitant IM) in first line generally varied between 10-20% (e.g., US: adalimumab (ADA), 10.8%; infliximab (IFX), 18.2%; EU5: ADA, 12.5%; IFX, 19.9%), though increased in later lines in the EU5. Among patients currently using a biologic therapy, between 10-40% of patients used a higher than indicated dose or greater than indicated dosing frequency during maintenance (e.g., US: IFX, 37.1%; ADA, 13.4%; EU5: IFX, 39.1%; ADA, 36.1%). In both the US and EU5, the primary reason for switching therapy was efficacy-related. In this analysis, many patients with moderate-to-severe UC use an IM or biologic as their first therapy after diagnosis. Combination therapy and dose escalation are also common, and underscore the challenges with managing this patient population.

Déclaration de conflit d'intérêts

We have the following interests: This study was funded by Pfizer Inc and was conducted by Adelphi Real World. AA has been involved in advisory boards for, and received research support from, Pfizer Inc, and has received research support from MSD and Takeda, lecture fees from AbbVie, Amgen, AstraZeneca, Chiesi, Ferring, Hospira, Janssen, Medtronic, Mitsubishi-Tanabe, MSD, Mundipharma, Nikkiso, Otsuka, Pfizer Inc, Takeda, TiGenix, Zambon, and consultancy fees from AbbVie, Allergan, Amgen, Biogen Idec, Bristol-Myers Squibb, Celgene, Celltrion, Eli Lilly, Ferring, Hospira, Janssen, MSD, Mundipharma, Mylan, Pfizer Inc, Samsung Bioepis, Sandoz, Sofar, and Takeda. JL, DBl, and BH acted as consultants for Pfizer Inc. MD, MT, JC, DQ, and LS are employees and stockholders of Pfizer Inc. DBa, was an employee of Pfizer at the time of the study and during manuscript development. JL, DBl and BH are employed by Adelphi Real World. There are no patents, products in development or marketed products to declare. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials.